Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection

Phase 3

Terminated

• Conditions: Pancreatic Cancer; Perioperative/Postoperative Complications

• Registration Number: NCT00014651
• Lead Sponsor: Mayo Clinic

Brief Summary

RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic resection. It is not yet known if vapreotide is more effective than no further therapy in preventing side effects of pancreatic resection.

PURPOSE: This randomized phase III trial is studying vapreotide to see how well it works compared to a placebo in preventing complications in patients undergoing surgery for pancreatic cancer.

Detailed Description

OBJECTIVES: I. Compare the efficacy of vapreotide versus placebo in reducing postoperative pancreatic complications in patients undergoing elective pancreatic resection. II. Compare the postoperative complications occurring within 45 days after surgery unrelated to the pancreas, days of hospitalization and survival at 45 days after surgery, number of rehospitalizations, and number of postoperative blood units or packed red blood cells administered in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients undergo surgical resection on day 1 and receive vapreotide subcutaneously twice daily on days 1-7. Arm II: Patients undergo surgical resection and receive a placebo as in arm I. Patients are followed at days 28 and 45.

PROJECTED ACCRUAL: A total of 580 patients (290 per arm) will be accrued for this study.

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2001-03
• Study First Submitted: 2001-04-10
• Study Completion: 2002-04
• Study First Submitted QC: 2004-05-04
• Study First Posted: 2004-05-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-06
• Last Update Posted: 2010-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (18)

NYU School of Medicine's Kaplan Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Moffett Cancer Center (South); 🇺🇸 Tampa, Florida, United States

Rush-Presbyterian-St. Luke's Medical Center; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Johns Hopkins Oncology Center; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Taubman Health Care Center; 🇺🇸 Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States